Spots Global Cancer Trial Database for Efficacy of Adjuvant Mitotane Treatment (ADIUVO)
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Trial Identification
Brief Title: Efficacy of Adjuvant Mitotane Treatment (ADIUVO)
Official Title: Efficacy of Adjuvant Mitotane Treatment in Prolonging Recurrence-free Survival in Patients With Adrenocortical Carcinoma at Low-intermediate Risk of Recurrence
Study ID: NCT00777244
Conditions
Interventions
Study Description
Brief Summary: Study Rationale Adrenocortical carcinoma (ACC) is a very rare disease with a high risk of relapse after radical surgery. The efficacy of adjuvant mitotane treatment is suggested by a retrospective multicenter international study showing that postoperative mitotane treatment was associated with a significant reduction of the risk of relapse and death. However, these promising results need confirmation in a randomized prospective study. Caution should be adopted particularly in patients with low risk of disease relapse, in whom the benefit of therapy should be weighted against the side effects. Even if an adjuvant treatment seems justified in patients at high risk of relapse, a randomised prospective study is needed to assess whether such a treatment is efficacious in patients at low-intermediate risk. The purpose of the present study is to determine whether adjuvant mitotane treatment is effective in prolonging the disease free survival in patients with adrenocortical carcinoma at low-intermediate risk of progression who underwent radical resection
Detailed Description: Endpoints Primary : To compare DFS (Disease Free Survival), defined as the time between the date of randomization until documentation of any of the following failures (whichever occurs first): -local or distant recurrence of disease;-death from any cause or completion of follow-up. Secondary: To compare OS (Overall Survival), defined as the time interval between the date of randomization and the date of death from any cause or the last known alive date;· To compare quality of life measured by EORTC-QLQ-C30· To compare toxicity, graded according to the NCI-CTG criteria;· To compare DFS and OS in patients who achieve or not serum mitotane concentrations \> 14 mg/L;· To compare DFS and OS between the 2 arms in patients subgroups stratified according to: type of hormone secretion, stage of disease, histopathologic characteristics.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medical Oncology Branch - Center for Cancer Research - National Cancer Institute, Bethesda, Maryland, United States
Endocrine Oncology - University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Endocrinologie - Centre hospitalier de l'Université de Montréal (CHUM), Montreal, , Canada
Endocrinologie - CHU Besançon Hôpital Jean Minjoz, Besancon, , France
Endocrinologie - CHU Lyon Hôpital Pierre Wertheimer, Bron, , France
Endocrinologie - Hôpital A. Michallon, La Tronche, , France
Endocrinologie - Cochin, APHP, Paris, , France
Endocrinologie - CHU Toulouse Hôpital Larrey, Toulouse, , France
Endocrinologie - Institut de Cancérologie Gustave Roussy, Villejuif, , France
University Hospital Campus Mitte Charitè, Berlin, Berlin, , Germany
University Hospital of Dresden, Dresden, , Germany
University Hospital of Düsseldorf, Düsseldorf, , Germany
Center for Endocrine Tumors - ENDOC, Hamburg, , Germany
University Medicin Centre of Munchen, München, , Germany
University Hospital Wuerzburg, Endocrinology, Wurzburg, , Germany
A.O.Universitaria Arcispedale S.Anna Ferrara, Ferrara, Fe, Italy
UO Oncologia Medica - AO Spedali Civili, Brescia, , Italy
Università degli studi di Firenze, Firenze, , Italy
Azienda Ospedaliera di Foggia, Foggia, , Italy
Ospedale Cà Granda-Niguarda-Milano, Milano, , Italy
Azienda Ospedaliera San Luigi, Orbassano, , Italy
Department of Clinical and Biological Sciences, University of Turin, Internal Medicine 1, Orbassano, , Italy
Azienda Ospedaliera Padova, Padova, , Italy
Università degli studi di Palermo, Palermo, , Italy
Policlinico Universitario A. Gemelli, Roma, , Italy
A.O.U. San Giovanni Battista - Molinette, Torino, , Italy
Dept. of Internal Medicine Maxima Medisch Centrum, Eindhoven, , Netherlands
Cancer Research UK Clinical Trials Unit (CRCTU) - School of Cancer Sciences - University of Birmingham, Birmingham, Edgbaston, United Kingdom
Contact Details
Name: Massimo Terzolo, MD
Affiliation: Internal Medicine, Department of Clinical and Biological Sciences, University of Turin, Italy
Role: STUDY_CHAIR
Name: Martin Fassnacht, MD
Affiliation: Department of Internal Medicine, University of Wuerzburg, Germany
Role: STUDY_DIRECTOR
Name: Alfredo Berruti, MD
Affiliation: Medical Oncology, Department of Clinical and Biological Sciences, University of Turin
Role: STUDY_CHAIR
Name: Eric Baudin, MD
Affiliation: Oncologie Endocrinienne et Médecine Nucléaire, Institut Gustave Roussy, Villejuif, France.
Role: PRINCIPAL_INVESTIGATOR
Name: Harm Haak, MD
Affiliation: Department of Internal Medicine, Máxima Medical Centre, Eindhoven, The Netherlands
Role: PRINCIPAL_INVESTIGATOR
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